Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00615849
• Collaborator: (none)
• Enrollment: 1,440
• Location: 1
• Duration (Months): 56
• Patients Per Site Per Month: 25.7

Study Details

Study Description

Brief Summary

For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.

Condition or Disease	Intervention/Treatment	Phase
Primary Spontaneous Pneumothorax	Procedure: thoracoscopic surgery	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1440 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. recurrence [follow up more than 1 year]

Secondary Outcome Measures

1. complications [follow up more than 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• recurrent pneumothorax

• bilateral pneumothorax

• total collapse/tension pneumothorax

• previous history of contralateral pneumothorax

• visible bulla on simple X-ray

• special occupation/situation

• air leakage more than 2 days with drainage catheter for 1st attack patients

Exclusion Criteria:

• patient refusal and reoperation case

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seungnam	Gyeonggi	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

• Principal Investigator: Sanghoon Jheon, M.D., Ph.D., Seoul National University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT00615849
• Other Study ID Numbers: KPT
• First Posted: Feb 14, 2008
• Last Update Posted: Sep 30, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital: pneumothorax, thoracoscopy, pleurodesis
• Additional relevant MeSH terms: Pneumothorax

Study Results

No Results Posted as of Sep 30, 2011